MDR

PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

Retrieved on: 
Monday, March 11, 2024
Certification, Aorta, MDD, Risk, Patient, Femoral artery, Medical device, Diastole, MCS, Interventional cardiology, MDR, Pump, PCI, Safety, Blood, Medical device regulation

The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.

Key Points: 
  • The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.
  • The iVAC 2L System is a percutaneous Mechanical Circulatory Support (MCS) device.
  • It can be used to facilitate high-risk Percutaneous Coronary Interventions (PCIs).
  • iVAC 2L represents a leap forward in complex High-Risk PCI's, and we are eager to make this transformative device available to healthcare providers and patients worldwide."

PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

Retrieved on: 
Monday, March 11, 2024
Certification, Aorta, MDD, Risk, Patient, Femoral artery, Medical device, Diastole, MCS, Interventional cardiology, MDR, Pump, PCI, Safety, Blood, Medical device regulation

The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.

Key Points: 
  • The MDR CE certification signifies PulseCath's commitment to the highest standards of quality and safety in medical devices.
  • The iVAC 2L System is a percutaneous Mechanical Circulatory Support (MCS) device.
  • It can be used to facilitate high-risk Percutaneous Coronary Interventions (PCIs).
  • iVAC 2L represents a leap forward in complex High-Risk PCI's, and we are eager to make this transformative device available to healthcare providers and patients worldwide."

Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

Retrieved on: 
Wednesday, April 3, 2024
Community, Civil service commission, Eurostat, Sneeze, Diagnosis, Granuloma, Cough, Prevalence, Cell, Disease, Infection, Tuberculosis, Central nervous system, Patient, Committee, Knowledge, Seriousness, Regulation, Bacteria, Meningitis, EMA, MDR TB, IRIS, Joint, Antimycobacterial, Periodic breathing, MDR, European, Fever, COMP, Safety, European Commission, Marketing, Lymphatic system, Pharmaceutical industry

Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

Key Points: 


Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline Treatment of tuberculosis, 26/08/2005 Withdrawn

OrbusNeich Achieves Record-High Revenue and Net Profit of US$154 Million and US$45.1 Million Respectively, Recommends Final Dividend Payment of HK10 cents per Share

Retrieved on: 
Thursday, March 7, 2024
Stent, Acquisition, MDR, Education, Cardiac catheterization, Sapphire, FDA, Marketing, Quality of life, Medical device regulation, PTCA, Physician, Growth, OrbusNeich, Medicare, PMDA, PTA, Abbott Laboratories, Percutaneous coronary intervention, Patient, Clinical trial, Knowledge, NMPA, Laboratory, Research, PCI

-- Revenue hit record high at US$153.9 million, up 12.5% year-on-year

Key Points: 
  • -- Revenue hit record high at US$153.9 million, up 12.5% year-on-year
    -- Revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year, respectively.
  • In particular, revenue from PCI balloons and PTA balloons grew by 12.1% and 29.0% year-on-year to US$115.4 million and US$14.7 million, respectively.
  • As at December 31, 2023, the Group was in a strong financial position with cash and bank balances amounting to US$255.8 million (2022: US$229.1 million).
  • Having considered future capital requirements, the Board has proposed a final dividend of HK10 cents per share in cash, as a token of appreciation for the continuous support of shareholders.

Cherry Launches Disinfectable Mouse and Keyboard Set for Hygiene-Sensitive Areas at HIMSS

Retrieved on: 
Monday, March 11, 2024
Scroll, CE, Hospital, MRSA, Disinfectant, FCC, USB, MDR, IP68, Peter Hancock (professor), Sleep, Methicillin-resistant Staphylococcus aureus, Computer, University, Cherry, Movement, Hygiene, Tablet, Laboratory, Research, Mouse, Typesetting

The new hygiene desktop is ideal for extensive entry in hospitals, doctors' surgeries, laboratories, other healthcare facilities, where disinfecting devices is mandatory.

Key Points: 
  • The new hygiene desktop is ideal for extensive entry in hospitals, doctors' surgeries, laboratories, other healthcare facilities, where disinfecting devices is mandatory.
  • When cleaning standard office keyboards, (even when internally sealed) contaminated cleaning fluids can potentially leak out of the gaps.
  • It is also possible the functionality could be impaired if liquids seep into the keyboard housing.
  • The Hygiene Desktop 2 is an individually configurable set consisting of the AK-C8112 hygiene keyboard and the AK-PMH3 3-Button Scroll and AK-PMH3 Scroll Sensor hygienic mice.

MSPs Have Voted and Huntress Takes Home Best Security Solution Award

Retrieved on: 
Wednesday, March 6, 2024
MSP, Expo Hall, Channel, Microsoft, SOC, MDR, Luigi

COLUMBIA, Md., March 06, 2024 (GLOBE NEWSWIRE) -- Huntress , the people-powered cybersecurity platform for small to mid-sized businesses (SMBs) and the managed service providers that support them, today announced it has been awarded Best Security Solution by MSPs who attended the ChannelPro event February 28-29 in Chicago.

Key Points: 
  • COLUMBIA, Md., March 06, 2024 (GLOBE NEWSWIRE) -- Huntress , the people-powered cybersecurity platform for small to mid-sized businesses (SMBs) and the managed service providers that support them, today announced it has been awarded Best Security Solution by MSPs who attended the ChannelPro event February 28-29 in Chicago.
  • The live event hosted a full house of managed service providers and notable channel experts who voted Huntress EDR and MDR for Microsoft 365 best security solutions, and Huntress’s booth presence as The Best in the Expo Hall.
  • “This award is another testament to the tremendous value that our products and our 24/7 human-led security operations (SOC) team bring to our MSP partners and their end customers," said Jordan Redd, Vice President of Channel and Customer Account Management for Huntress.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Spero Therapeutics to Provide Business Update and Report Fourth Quarter and Full Year 2023 Financial Results on Wednesday, March 13, 2024

Retrieved on: 
Wednesday, March 6, 2024
ID, Therapy, Spero, Infection, MDR

ET to report its fourth quarter and full year financial results and provide an update on its business and pipeline.

Key Points: 
  • ET to report its fourth quarter and full year financial results and provide an update on its business and pipeline.
  • To access the call, please dial 1-877-704-4453 (domestic) or 1-201-389-0920 (international) and refer to conference ID 13744458, or click on this Link and request a return call.
  • The audio webcast can be accessed on the "Events and Presentations" page under the “Connect” tab of the Company's website at www.sperotherapeutics.com .
  • The archived webcast will also be available on Spero's website for 30 days following the call.

CooperCompanies Announces First Quarter 2024 Results

Retrieved on: 
Thursday, February 29, 2024
Acquisition, GAAP, Bank statement, Forecasting, MDR, Rationalization, Public expenditure, Bank

The Company's four-for-one stock split became effective after close of trading on February 16, 2024, and began trading on a stock split-adjusted basis on February 20, 2024.

Key Points: 
  • The Company's four-for-one stock split became effective after close of trading on February 16, 2024, and began trading on a stock split-adjusted basis on February 20, 2024.
  • To supplement our financial results and guidance presented on a GAAP basis, we use non-GAAP measures that we believe are helpful in understanding our results.
  • We believe it is useful for investors to understand the effects of these items on our consolidated operating results.
  • We exclude the effect of acquisition and integration expenses and restructuring expenses from our non-GAAP financial results.

Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections

Retrieved on: 
Wednesday, February 28, 2024
Pfizer, Infection, MDR, FDA, Food, Trial of the century, Prevalence, Safety, Fungal infection, Therapy, Pharmacokinetics, Disease, Gram-negative bacteria, Patient, IND, Mortality, VABP, Pharmaceutical industry

SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections.

Key Points: 
  • SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections.
  • "Clearance of this IND is an important milestone in our SPR206 development program, as we prepare to advance this drug candidate into a Phase 2 trial in HABP/VABP," said Kamal Hamed, Spero’s Chief Medical Officer.
  • "HABP/VABP are serious infections associated with high mortality and substantial morbidity, and their management has been complicated by the increasing prevalence of difficult-to-treat and MDR Gram-negative pathogens.
  • SPR206 is subject to a license agreement with Pfizer Inc., which was made alongside Pfizer’s $40 million equity investment in Spero, previously announced in June 2021.